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Early prediction of menopausal status in pre/perimenopausal women with early breast cancer after (neo) adjuvant chemotherapy in order to optimize adjuvant endocrine therapy


- candidate number23354
- NTR NumberNTR5575
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-nov-2015
- Secondary IDsMEC13-156 Erasmus Medical Center
- Public TitleEarly prediction of menopausal status in pre/perimenopausal women with early breast cancer after (neo) adjuvant chemotherapy in order to optimize adjuvant endocrine therapy
- Scientific TitleEarly prediction of menopausal status in pre/perimenopausal women with early breast cancer after (neo) adjuvant chemotherapy in order to optimize adjuvant endocrine therapy
- ACRONYMAMH study
- hypothesisCan absolute AMH levels, measured before start of (neo)adjuvant chemotherapy, correctly predict recovery of ovarian function within the first two years following (neo)adjuvant chemotherapy in pre/perimenopausal patients with early breast cancer?
- Healt Condition(s) or Problem(s) studiedBreast cancer
- Inclusion criteriaInclusion criteria:
• Primary hormone-sensitive (ER >10% positive and/or PgR >10% positive) breast cancer, independent of Her2- receptor status, curatively locally treated
• Age 46 years
• Indication for (neo-)adjuvant chemotherapy according to the Dutch Guidelines for breast cancer treatment (2012)
• Pre- (regular menstrual cyclicity) and perimenopausal women (amenorrhea duration of less than 12 months) before the start of (neo-) adjuvant chemotherapy
- Exclusion criteriaExclusion criteria:
• Bilateral oophorectomy
• History of hysterectomy (no information on menstrual cycle possible)
• Evidence of distant metastases
• Use of GnRH agonists within 12 months before the start of (neo-) adjuvant chemotherapy
• Use of hormone-containing intra-uterine device (Mirenaฎ), irrespective of age at breast cancer diagnosis (use of copper-containing devices is allowed)
• Chemotherapy prior to inclusion in the study
• Use of aromatase inhibitors or tamoxifen <6 months before start of (neo-) adjuvant chemotherapy
• History of pelvic radiatiotherapy
• History of treatment with cytotoxic chemotherapy
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jun-2013
- planned closingdate
- Target number of participants100
- Interventionsno intervention
- Primary outcomerecovery of ovarian function is defined as resumption of menstrual cyclicity (at least more than 1 episode of vaginal bleeding, not caused by vaginal atrophy) and/or levels of estradiol and FSH in the postmenopausal range (according to the local laboratory values; in general >110 pmol/l and <20 pmol/l, respectively), being reconfirmed at least once.
- Secondary outcomenvt
- Timepointsnvt
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. A. Jager
- CONTACT for SCIENTIFIC QUERIESDr. A. Jager
- Sponsor/Initiator Erasmus MC Cancer Institute, department of Medical Oncology
- Funding
(Source(s) of Monetary or Material Support)
Pink Ribbon
- Publicationsnot yet
- Brief summary
- Main changes (audit trail)
- RECORD11-nov-2015 - 14-feb-2016


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